By Cambridge Design Partnership

September 14th 2022

Designing more sustainable electronics

From phones to laptops, home devices to watches, electronic devices – particularly smart devices – have become part of people’s lives, enabling better communication and access to information and making their day-to-day easier.

But the increasing adoption of technology comes at an environmental cost. Electronic devices often have a significant carbon footprint because of the energy-intensive processes needed to produce printed circuit boards (PCBs) and integrated circuits.

Electronics production relies on mining and extracting dozens of different materials, including critical raw materials (economically important materials at high risk of supply shortage, such as lithium or titanium). Extracting these materials has a range of sustainability impacts, including the leakage of toxic chemicals such as cyanide into the environment, high levels of water use, and human rights abuses in the case of ‘conflict minerals’ such as gold and tantalum.

Waste electronic products, or e-waste, is the fastest-growing waste stream in the world, with over 53 million tonnes of e-waste produced in 2019. Most e-waste is disposed of incorrectly, ending up at waste dumps in developing countries. Hazardous chemicals, such as lead or mercury, that may be present in electronic components can leak into the environment, harming local ecosystems and damaging the health of people who live and work in the dumps.

Product sustainability has focused on the circular economy, particularly recycling. But there are fundamental limits to the impact recycling can have on electronics. Only 17% of e-waste is collected for recycling and, even if it’s collected, recovering materials from e-waste is particularly challenging.

Electronics contain trace amounts of rare metals, which are complex and expensive to separate. Only the most abundant materials, such as copper and gold, can be economically retrieved during e-waste recycling, and even if all e-waste was recycled in this way, the material recovered still wouldn’t be enough to meet the growing demands of the industry.

One way to tackle the environmental challenges presented by electronics is to remove the need for them in the first place, for example by detecting a temperature change using a color-changing chemical rather than a sensor. But, in some instances, electronics are necessary, so how can designers reduce the impact of the products they create?

Our sustainability team assessed a range of technologies and design techniques to determine their potential for reducing the environmental impact of electronic products and how difficult they are to implement. This article outlines a few approaches we’ve used in recent projects at CDP.

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Reducing complexity through connectivity

One of the best ways to reduce an electronic device’s environmental impact is by minimizing the electronics’ complexity, thereby reducing the number of integrated circuits needed as well as the surrounding passive components (resistors, capacitors and so on), connecting tracks, and PCB area.

An easy, effective way to do this is by pairing a product with a user’s existing device to provide the smart capability. Methods range from a simple QR code or NFC chip to a Bluetooth connection for transferring more complex data.

As well as reducing the electronics in the product, this allows for a degree of futureproofing, as software updates can be used to keep the product up to date. This idea isn’t new but is starting to be used more in applications from smart packaging to medical devices.

Important to note: Behind many of these software solutions are large data centers that need powering and should be considered in the product’s environmental impact.

Informed decision-making: Life Cycle Assessment (LCA)

Designers can optimize component choices and circuit designs during detailed design to reduce the overall impact of a product.

We recently used LCA to estimate the additional carbon footprint of adding an electronic module to a medical device. This step allowed our team to identify where to focus on reducing the impact of the design, such as replacing integrated circuits with a solution based on lower-impact passive components and optimizing the layout to minimize the total area of PCB required.

We identified several solutions that together had the potential to reduce the total carbon footprint of the product by up to 25% without compromising functionality. In many cases, this optimization also generates cost savings.

Optimizing electronics through additive manufacturing

Over the past two decades, additive manufacturing (such as 3D printing) has seen a surge in use in mechanical prototyping and manufacture, and its applications in the electronics sector are now starting to grow. In the context of PCBs, additive manufacturing refers to selectively adding conductive material to the areas required, as opposed to a more traditional approach which starts with a layer of copper and selectively etches away the areas where it isn’t needed.

These technologies can improve a product’s carbon footprint through reduced material usage and less energy-intensive manufacturing processes. A report published by the ECOtronics project found, “Changing from subtractive manufacturing (etching) to additive manufacturing (printing) has the potential to reduce environmental impacts by more than 50% across all impact categories.”

One additive manufacturing method is laser direct structuring (LDS), which allows you to construct circuits on the surface of device components. With this approach, you can remove the PCB entirely, dramatically cutting down on the material required.

These technologies present opportunities to fit electronics into new form factors, print onto a wide array of rigid or flexible substrates (the non-conductive part of the circuit board the metal circuit is added to) and increase the customizability of the design, all while reducing the product’s environmental impact.

As we’ve highlighted before, sustainability initiatives should always consider context, which is vital for electronics. In the absence of cost-effective recycling processes, designers must prioritize approaches that reduce the materials and energy required to produce electronics. As electronics continue to play a leading role in our lives, future designs should reduce our reliance on critical raw materials and consider how circular approaches to design can extend product lifetimes and prevent harm to people and the environment.

References

Conflict minerals used in IT products drive wars and human rights abuses [Internet]. TCO Certified. [cited 19 August 2022]. Available from: https://tcocertified.com/conflict-minerals/
Global E-waste Monitor 2020 [Internet]. ITU. [cited 19 August 2022]. Available from: https://www.itu.int/en/ITU-D/Environment/Pages/Spotlight/Global-Ewaste-Monitor-2020.aspx
ECOtronics [Internet]. ECOtronics. [cited 19 August 2022]. Available from: https://www.ecotronics.fi/

April 14th 2022

Find the authors
on LinkedIn:

Jonathan Wilkins

Senior Consultant Mechanical Engineeru202f

Emma Lindsey

Associate Mechanical Engineer

How to boil your egg perfectly every time – according to simulation

Search ‘how to boil an egg’ on Google, and you get over three billion results, some telling you to put the egg in cold water after boiling to preserve the runny yolk. Intrigued, we decided to investigate the science behind this advice.

Rather than heading straight to our lab for experimentation, we used computer simulation to calculate and model the movement of heat and temperature through the egg and surrounding fluid. Simulation lets us predict data at times that would be impractical or expensive in actual experiments.

Modeling the heat flow in a boiling egg could be a surprisingly tricky problem. An egg consists of a solid shell holding the white and yolk, initially in a liquid state but solidifying as the cooking continues. Being natural products, the exact properties and sizes of eggs vary.

To simplify the problem, we found technical publications that describe the average dimensions and thermal properties of the shell, white, and yolk for a typical egg. We decided to define these properties at a temperature of 60°C, which is around the point the yolk starts to solidify. Using computer-aided-design software, we created the geometry of the egg, and defined a body of fluid to surround it. This fluid body represents the boiling water in a saucepan during the first cooking stage. Afterward, the fluid body can be used to mimic cool-down in air or a bowl of 10°C cold water. We decided that the eggs would start the process from room temperature in all cases.

We ran the simulation using powerful software, Ansys Fluent. The software was initially developed for understanding problems such as the flow of air over planes or heat in a chemical plant, but it can be applied to domestic problems such as the humble boiled egg. To allow the simulation to run quickly on an ordinary computer, we took advantage of the fact an egg shape is a body-of-revolution and looks the same however it’s rotated around its axis. This lets us model it as an axisymmetric body that the computer considers two-dimensional. This reduces the number of calculations and gives us the answer quicker and more cheaply than simulating the real-life, three-dimensional shape.

As an example of the simulation results, Figure 1 shows the temperature distribution on a slice along the egg’s axis after cooking in boiling water for six minutes. The material towards the outside has heated up close to the temperature of the water. However, the central region corresponding to the yolk is still around 50°C, corresponding to a runny egg.

Figure 1: Temperature distribution on a slice across the egg after six minutes of immersion in boiling water.

Figure 2 shows a side-by-side comparison of subsequently cooling the egg in air or 10°C water for five minutes (five minutes being our estimate of the time it takes to finish eating our first dippy egg and move on to the second). When cooled in air, the central region of the egg continues to increase to 70°C, removing the prospect of a runny egg, even though the outer region and shell have decreased in temperature. In contrast, after cooling in water, the central region stays unchanged at 50°C while the shell has decreased close to 10°C. Leaving your perfect dippy egg in air risks ruining the runny yolk – but cooling it in water may save it.

Figure 2: Temperature distribution on a slice through the egg following cooking
and five minutes of cooling in (a) air and (b) water.

As well as modeling the overall temperature in the egg, we extracted the data for two specific points – at the center and the edge of the egg – and plotted them on a graph (Figure 3) to see how they differed. The data showed that the yolk’s temperature lags that at the shell. This is because the thermal diffusivity of the white and yolk are relatively low. Thermal diffusivity is a measure of how quickly heat can move through a material. So, it takes a while for the yolk to heat up, but once it does, it keeps cooking, absorbing heat from the rest of the egg material. It’s slow to respond to changes in the surrounding water (or air). The temperature just inside the shell responds much more quickly to changes, though, since the path the heat needs to travel from the surrounding fluid is considerably shorter, and the thermal diffusivity of the shell markedly higher.

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Figure 3: Temperature profiles with time at the center point of the yolk (circles) and adjacent to the shell (crosses)

With the aid of some considered simplifications, we think this simulation analysis has proven the cookery expert right: cooling eggs down in cold water really does preserve the runny yolk. However, whenever you analyze a problem for the first time, it’s important to compare results against an experimental benchmark, so you can confirm the realism of the assumptions and simplifications in a computer simulation. We took three eggs and boiled each for six minutes in a lab beaker. One was opened straight away, and the other two after cooling in cold water or in air for five minutes. As predicted by our computer simulation, the yolks ranged from runny to fully cooked. And the best thing about this experiment? Everyone got an egg cooked precisely to their liking at the end.

By Matt Morris and Dan Haworth

April 5th 2022

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on LinkedIn:

Matt Morris

Sustainability Leadu202f

Dan Haworth

Head of Diagnostics

Reducing the carbon footprint and plastic waste of LFTs: Evidence-based opportunities

Billions of lateral flow tests have been used worldwide during the COVID-19 pandemic – over two billion have been provided in the UK alone. Debate has raged on social media about why the tests need to use so much single-use plastic and how they could be made more ‘sustainable’. The test strip caseworks is a particular source of dismay – why so much plastic to house such a tiny test strip?

With the UK government ending the free distribution of lateral flow tests for the general public – citing a transition from emergency response to longer-term management of the pandemic – now is the ideal time to look more closely at the sustainability of these lateral flow tests, and to seek the data to demystify some of the emotional assumptions being made.

Familiarity with lateral flow testing has certainly increased, as has confidence in their clinical performance. It’s expected that lateral flow devices will be more present in our daily lives post-pandemic – not just for COVID-19 and pregnancy testing but to diagnose diseases such as seasonal influenza and sexually transmitted infections – all from the comfort of the home.

We’ve carried out a high-level assessment to quantify the approximate environmental impact of lateral flow tests and identify evidence-based suggestions for improving their environmental sustainability.

Why do COVID-19 lateral flow tests contain lots of single-use plastic in the first place?

The emergence of COVID-19 was a global emergency, and vast quantities of lateral flow tests were needed urgently. Once developers could produce the right immunoassay chemistry to detect the virus (SARS-CoV-2), it required implementation in a low-cost, low-risk device, that has a mature supply chain – with proven, readily available materials that wouldn’t compromise analytical or clinical performance.

This meant using existing plastic casework designs to retain and protect the nitrocellulose test strip. Plastic is robust, low cost, lightweight, easy to transport, and easily printed for QR codes and LOT numbers. Critically, it’s a consistent material proven for the highest volume manufacturing and won’t interfere with the immunoassay chemistry.

From a performance, cost, and manufacturing perspective, redesigning the product with new materials would have been high risk. Material changes may also have needed significant R&D costs, new capital equipment as well as additional cost and effort needed to demonstrate equivalence and achieve regulatory approval – risking the ability to provide sufficient numbers of high-quality tests, at speed during the pandemic.

Our results: The sustainability of lateral flow tests

But how serious an environmental impact do these tests have? To find out, we broke down a test into its constituent components and weighed them to calculate the approximate environmental impact, using standard emissions factors to calculate the carbon footprint of a single test.

We focused on carbon footprint (the carbon dioxide and other greenhouse gases emitted during manufacture, transport, and disposal of the tests) and plastic waste (waste that would persist indefinitely if released into the environment) – the two issues that have attracted the most attention around lateral flow tests. A more comprehensive study should consider a broader range of environmental impacts, for example, the use of scarce resources and emission of other pollutants to avoid unintended consequences of any product changes.

Our results reveal:

The components needed to conduct the test account for around half of the carbon footprint and around two-thirds of the plastic waste. Packaging makes up most of the rest – as is often the case, a surprisingly high proportion of the total environmental impact
The test strip caseworks, which attracts the most comment online, is responsible for around 30% of the carbon footprint and 40% of the plastic waste. While it’s the most significant single contributor to the environmental impacts we evaluated, the large number of other small parts is also significant. Focusing on the caseworks therefore might not be the best strategy for improving the sustainability of the tests overall.

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Lateral flow tests a minor piece of UK healthcare’s environmental impact

To put these numbers into context, we can compare the environmental impact of the two billion COVID-19 lateral flow tests distributed in the UK with the UK healthcare system’s overall environmental impact. We estimate the UK’s lateral flow tests have a carbon footprint equivalent to around 0.5% of the total NHS carbon footprint. This isn’t a trivial amount, but it’s also not the largest single contributor to the impact of the UK health system.

It’s also worth considering the positive environmental impact of a user-administered test on the health system. Conducting a test at home can eliminate the need for an individual to visit a test site, GP’s surgery, or hospital (assuming the clinical performance of the lateral flow test is adequate). Based on estimates from the Sustainable Healthcare Coalition, one lateral flow test has around 5% of the carbon footprint of a single GP appointment and produces a similarly low percentage of non-degradable (plastic) waste.

And that’s before we consider travel. We estimate one lateral flow test has the same carbon footprint as driving 350 metres in an average UK car. So, if you’re driving yourself to a test site or GP surgery some distance away, at-home lateral flow tests compare even more favorably.

If a lateral flow test prevents an individual from transmitting COVID-19 to a vulnerable person, there’s a public health benefit – as well as an environmental benefit – to keeping people out of the hospital. We can all see the discarded waste from home tests, but the less visible impact from energy- and material-intensive medical interventions is often significantly higher.

These approximate figures demonstrate why building an evidence base is vital during product development targeting sustainability objectives – because the results can be unexpected and non-intuitive.

Quick ways to optimize today’s lateral flow tests

Just because waste from lateral flow tests might not be the most urgent sustainability issue for UK healthcare, that doesn’t mean we can’t and shouldn’t do something about it.

We used the ‘avoid/shift/improve’ model to find potential quick wins for lateral flow tests. These reduce the carbon footprint of each test by nearly a third and the plastic waste by almost a quarter – without impacting the fundamentals of how the test works.

They include:

Eliminate waste bags. There’s a case for quickly isolating contaminated waste (even given COVID-19 also spreads from infected individuals through the air), but the bags account for around 5% of the carbon footprint of the test. It’s not clear how widely used they are in a domestic setting – there may be a risk-based justification for not including them in the test kit.
Package all the test strips in a single foil pouch. Using a single re-sealable pouch to protect the tests from ambient humidity (rather than individually packing each test in a pouch with desiccant) is common in packs of lateral flow tests designed for use by healthcare professionals. However, once opened, the stability lifetime of the remaining tests is affected.
Reduce the size of paper instructions. These are important for the effectiveness of the tests and are a regulatory requirement, but account for 5% of the carbon footprint of a test – could they be reduced in size?
Eliminate the cardboard sleeve. This packaging isn’t essential to the safe and effective functioning of the test, and it seems likely that the functions it does provide could be achieved with less material.
Prefill the extraction tubes with buffer solution. This is already done in some test kits, although manufacturers need to be conscious of moisture loss and the effect on shelf life. However, the separate plastic vial used in the test kit we studied accounts for around 5% of the carbon footprint and plastic waste.
Increase the size of the pack from seven to ten tests. This would mean less package waste per individual test. Including ten tests in one pack instead of seven reduces the carbon footprint by around 5% (depending on how many other optimizations are done at the same time). Perhaps a pack of seven tests was originally designed to cover a week of daily testing – but is that how tests are being used in practice?

Redesign of the test strip caseworks

Looking to the longer-term gets us into product redesign – creating a new generation of the product with sustainability in mind. Doing this can take significant investment since, for medical devices, it’s likely to require new regulatory approval, which is a lengthy and costly process.

A popular idea circulating for lateral flow tests is to minimize the plastic test strip caseworks (without compromising the essential functions of providing a stable platform, and protecting the nitrocellulose test strip). It might be possible to halve the caseworks mass and reduce the overall carbon footprint and plastic waste by 15-20%. This would require significant investment in R&D, production tooling, and regulatory approval hoops to jump through – but could be worthwhile if future demand for tests stays high.

Longer-term options

If we consider that the world may require billions more lateral flow tests over the coming decade, a more comprehensive redesign becomes commercially viable. This could involve stripping the design back to the fundamental requirements for a lateral flow test – flowing a sample through the test strip in a way that is controlled and free from contamination. Current designs take advantage of established components to collect, buffer, and dose the sample – but, at this production volume, it may be worthwhile designing a system from the ground up that is optimized for cost, usability, performance, and sustainability.

Sustainability as a brand differentiator

It’s clear there’s scope to optimize lateral flow tests to reduce their environmental impact – and a systematic analysis reveals options beyond those that might jump out to someone when they use the tests. But it’s essential to put the impact of lateral flow tests in the context of the wider healthcare system, to focus resources where they can have the most environmental impact – and to recognize that, sometimes, the plastic waste people can see helps to avoid more serious, but less visible consequences.

On the other hand, while visible plastic waste from lateral flow tests may not be the most pressing environmental issue facing the healthcare industry, it highlights the growing influence consumer opinion is likely to have as diagnosis and treatment shift from hospitals to homes. And as lateral flow tests become (in the UK, at least) a product people buy with their own money, choosing from a range of options, there may be a competitive advantage for businesses that take note and optimize their products for sustainability.

Featuring analysis conducted by Katie Williams, Mechanical Engineer

References

Prime Minister sets out plan for living with COVID [Internet]. GOV.UK. 2022 [cited 1 April 2022]. Available from: https://www.gov.uk/government/news/prime-minister-sets-out-plan-for-living-with-covid
The Sustainable Healthcare Coalition. Care Pathways Calculator. [Internet]. Sustainable Healthcare Coalition. 2022 [cited 1 April 2022]. Available from: https://shcoalition.org/

By Jon Powell

January 18th 2022

Find the authors
on LinkedIn:

Jon Powell

Senior Consultant, Manufacturing

Prepare the way: Pilot manufacture for drug delivery devices

Bringing a drug delivery device to a clinical trial is a complex endeavor. You need to keep a handle on multiple moving parts, for example, the active pharmaceutical ingredient (API) development, the regulatory pathway, establishing the supply chain, and labeling. Developing a novel drug delivery device takes things to another level.

Many manufacturers shy away from the challenge, relying instead on proven technologies, so patients and clinicians don’t benefit from the most advanced user-centered design, and pharma companies can’t leverage the competitive advantage new technology delivers.

Here, I share some of the obstacles encountered conducting pilot builds in-house to help our clients bring devices to market – and give four pointers for ideal pilot manufacturing for clinical trials.

Develop your manufacturing process and architecture in tandem

3D CAD makes it all too easy to lose touch with reality and forget that the model on the screen is only an idealized representation. Zoom in 4,000%, and everything lines up beautifully. There’s no gravity, and parts have infinite stiffness, no tolerance, and perfect alignment. But, when you get natural variation in the manufacturing process, results can be disastrous. Components may not even fit together.

Once a design is frozen, making changes is expensive. After it’s passed to a high-volume manufacturer, costs become exponentially higher. Understanding manufacturing processes – and how changes can impact a project’s timeline – is critical for successful delivery. You need to prepare for the supply-chain ‘whiplash effect’: a tiny change at the top of the chain can mean seismic shifts at the end of it. That knock-on is the reason your product development strategy should incorporate pilot manufacture. Pilot manufacture keeps this effect in check by minimizing the volumes involved.

It’s vital to consider the whole supply chain, not just the component manufacturer, but the process equipment partners, filling, packaging, sterilization, and logistics. Each step has requirements to be understood and communicated to relevant parties. By developing manufacturing and assembly processes in tandem with device design, we can be flexible to insights arriving from either direction.

Pick the right partners for success

One of my first jobs was for a major automotive company. In their heyday, they ran the foundries that made the ball bearings for their vehicles. Today, they wouldn’t dream of it. No company does everything anymore. Few organizations would claim to be experts in all areas of drug delivery. Even those that manufacture and fill their own devices rely on external partners to produce the plastic resin and packaging materials and often outsource activities such as sterilization.

Partnering with experts to contribute specific knowledge is a time-efficient way to overcome obstacles in the development pathway. It also unlocks access to cutting-edge equipment and facilities that are expensive to maintain. While developing a breath-actuated inhaler, we engaged an external test house to conduct bio-compatibility evaluations on the device. We may have the skills in-house to perform this testing but maintaining accreditation for an activity that isn’t core to our business doesn’t make financial sense.

Know the limits

When developing a device, it’s essential to explore sources of potential variation. The same goes for the manufacturing process. You can use various tools to do this, but we frequently return to the humble ‘process failure modes and effects analysis’ (pFMEA). The pFMEA is a structured way to consider all the process steps – and how they could go awry. Developing a robust pFMEA ensures the team focuses on the highest risk areas and starts thinking about implementing mitigations.

A key checkbox for each manufacturing process step is if the results can be verified or validated. The US Food & Drug Administration Code of Federal Regulations Title 21 defines verification as “confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.” Many processes can be verified using in-process measurement systems. But several can’t, for example, the joining of two plastic parts by ultrasonic welding. You can’t determine the strength of this weld without destructive testing. The ultrasonic welding process needs to go through process validation to determine the limits within which the process should be operated.

When communicating with stakeholders, it’s crucial to know the volume limits and have a realistic plan for producing parts representative of the final production process. For example, how many parts can the mold tools make? There’s a trade-off between tool production speed, tool cost, and tool life. Low-cost soft aluminum tools might be ready in two weeks but only suitable for 2,000 shots, whereas a more expensive hardened steel version might take 16 weeks (without validation) but last for over 100,000 shots.

Validating injection mold tools can be a lengthy process. Exploring the process window needs planning and performing multiple molding and measurement runs and subsequent analysis. Companies only want to bear this cost once, so experienced development teams need to hold firm when encountering adverse test results. I know of an auto-injector that showed promise early on, albeit with an infrequent failure observed in testing during development, that was allowed to pass into design freeze. More thorough testing during design verification revealed results that triggered the regulatory application to be rejected. Cue months of tooling validation needing to be reassessed.

Combination products require the delivery devices to be filled or co-packaged with primary containers of the API. Clinical trials complicate this because they need devices filled with the API or safe and sterile placebo. The filling process can be complex, especially when the API is highly viscous or uses technologies such as microspheres to sustain the release of active components over time. You need to factor in time to explore the filling and develop the process settings. Thought needs to be given to the amount of API and placebo available and the lead times for new batches as this can limit the amount of filled and finished devices.

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Not documented? You’re not done.

Understanding the controls needed to manage risk is essential for a manufacturer delivering high-quality, safe, and reliable products. ISO 14971 sets out a best practice framework for managing risk in the context of medical devices. We advise creating a quality control plan that summarizes the production risk mitigation controls identified through risk assessment in a clear, concise format. This control plan also blueprints the actions needed if a specific limit or check is breached.

Anyone who has experienced an audit by a notified body or regulatory agency will recognize their love of records. The mature management systems used by large manufacturers often aren’t available for the short-run low volumes involved at the scale-up stage. Building a bespoke database compliant with 21 CFR part 11 to handle records can be a lengthy activity, particularly when compared with the pace of setting up paper-based systems.

Managing paper records generated by the manufacturing process can be challenging, putting storage and recall burdens on a manufacturer. Companies scan these documents soon after completion to reduce this burden. But the destruction of originals is risky, and the recall and integrity of e-records must be checked before destruction.

Pilot manufacturing helps optimize the journey of a drug delivery device to clinical trial. It’s not without its own challenges, but synchronizing manufacturing process and device design development, partnering with experts, having a plan for producing components that’s representative of the final production process, and keeping a handle on records puts you in a position to maximize pilot manufacturing’s potential.

References

CFR – Code of Federal Regulations Title 21 [Internet]. Accessdata.fda.gov. 2021 [cited 21 December 2021]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.3

By Cambridge Design Partnership

June 7th 2021

Ten ways to reduce E-waste in product development

We all have that drawer – the graveyard for discarded electronics. What’s in yours? A cracked phone, an obsolete activity tracker, maybe an original iPod? You hang onto them, because it seems wrong to throw them away.
You’re right. Globally, 53.6 million metric tons of electronic waste, or E-waste, were generated in 2019 but only around one-fifth of this was recycled. Roughly half this pile comes from personal devices, which can be hard to round up from consumers.

Any product that includes some form of circuitry or electrical components is classed as electronic equipment. Once this product has been discarded without the intent to reuse, it falls under the category of E-waste.

The problem is not just environmental; in some cases it’s pragmatic. Many minerals in the products we throw away are difficult to obtain. The long-term consequences are serious. For example, a shortage of lithium or cobalt, both critical materials in electric vehicle batteries, could slam the brakes on our migration to greener transport.

As with most environmental issues, the solution to E-waste lies with government, industry, and the consumer. This article focuses on how product developers can play their part in helping to reduce e-waste.

Ten ways to reduce E-waste

1. Think modular

If devices become more modular, it becomes easier for the consumer or an engineer to perform repairs. It also makes it easier to break up devices at the end of their lives, a growing incentive if more industries become responsible for waste disposal.

Small product changes can make a significant impact, for example identifying which components tend to break first. Is there a way to make the component easily removable and replaceable? And if not, could it be designed to be more resilient?

2. Anticipate legislation

E-waste is a growing area of concern for governments, leading to a marked increase in the regulatory restrictions on disposal. This is noticeable in the electric car industry, where the EU and China have made manufacturers responsible for collecting and disposing of car batteries.

Both regulation and taxation are likely to increase. There is an opportunity for product developers to anticipate these factors when designing new products.

3. Respect the Right to Repair

A generation ago, mending your own possessions was a standard solution. Commonplace electrical repairs involved a loose wire or blown fuse. Today, electronic goods are much harder to fix, not helped by moving from screws to adhesive in assembly. You can no longer replace the battery in your phone and must go to a specialized repair shop for a damaged screen – think back to that drawer of retired electronics.

Product reviews now include ratings for ease of repair. France has introduced a law requiring an index of repairability which has encouraged manufacturers to offer online fixing guides. Other EU countries are rolling this out, including a requirement for manufacturers to ensure that spares are available for up to a decade. Sweden is also reducing the VAT rate on repairs and spare parts.

The ‘Right to Repair’ is a growing consumer rights issue. Designers can reduce E-waste by making it easy to mend common faults.

4. Use recyclable materials

As materials and processing research have progressed, the range of options for easily recyclable electronics has increased. These vary from paper RFID tags and biodegradable PCB substrates to chemical methods for breaking down coatings which have traditionally complicated the recycling process. These are all options to keep in mind when starting a design.

5. Design for E-waste recycling early on

The E-waste recycling process has the potential to be very expensive, so designing with this in mind early on is vital. There is also the challenge of encouraging consumers to return their devices in the first place. It’s much more challenging to recycle post-consumer waste than materials still under the manufacturers’ control.

Material resources for electronic devices are becoming increasingly difficult to source and therefore more expensive. This highlights the benefits of setting up a ‘reverse supply chain’ in which waste products are returned to their suppliers for recycling, allowing manufacturers to extract reusable materials.

The electronics in many home appliances often only make up a tiny proportion of the product. If a more modular design is selected, it becomes far easier to separate the E-waste from the product for recycling.

6. Top the ratings

Concerns over “fast fashion” in the retail industry could easily translate into customers rejecting low-cost, short-lifetime electronic products.

A public rating system for electronics that includes ease of recycling and repair as two separate metrics would prompt brands to question their design choices. Are there other less toxic or less scarce materials that could be used instead? Are there different versions of the product with lower E-waste potential?

Eupedia, an online guide to the EU, recently combined four indices covering a range of sustainability factors to rank brands, including ratings for recycling and repair.

7. Question whether electronics are necessary

Recently, electronics with ever-increasing features have been incorporated into previously ‘dumb’ products. In many cases, this enables functionality that was previously unachievable. However, sometimes we can obtain the same advantages without electronics, leading to a lower-cost and more straightforward solution.

Designers should carefully consider the range of solutions available and weigh up the relative user benefits, costs, and environmental impacts to find the most appropriate one for their product. For a simple maximum temperature monitor, do electronics provide a unique additional benefit, or can a different type of innovation such as a chemically triggered color change give the same information to the user?

8. Partner with smart devices

The obvious way to reduce E-waste is to produce less in the first place, but is this realistic? One route is to design electronics-free devices made smart through combination with a phone app. This often allows for the same functionality with no extra electronic components. For example, in diagnostic healthcare, agriculture and food safety testing, a phone camera can read and analyze colored test strips.

9. Consider a more sustainable business model

Some companies, such as Rolls Royce jet engines, have pioneered a service business model, in which customers hire products and return them to the supplier after use. This allows the manufacturer to perform necessary repairs or replacements between hire periods. Under this model, the burden of recycling shifts back to the supplier, further encouraging them to design products with minimal E-waste.

10. Reduce material usage

Mobile phones have shrunk in size from a brick to a calculator. This has been made possible by the miniaturization of electronic components, printed circuits, and connectors. The amount of material contained within each device has reduced considerably, even though complexity has increased.

Moving from milling and other subtractive manufacturing technologies to molding and 3D printing has reduced waste. There are opportunities to mirror these changes in electronics. Instead of making a flat sheet of copper and then dissolving most of it to produce a printed circuit board, additive techniques such as printed electronics can lay down patterns of conductors and insulators only where they are needed.

Putting E-waste in context

Our customers want smaller, lighter, longer-lasting devices that are easy to recycle. We can take all these factors into account every time we create a new design.

Solutions to E-waste must be looked at in the unique context of a product’s market and usage.

If we follow rules such as the above, we will make the optimum use of our planet’s limited material resources, and lay the electronics graveyard drawer to rest.

Which improvements will you design into your next electronic product? Want to discover more and connect with our sustainability experts?

By Steve Augustyn

April 1st 2021

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Steve Augustyn

Senior Consultant Mechanical Engineer

ISO 11608: All change for injector standards

Anyone who works with injection devices will be familiar with the ISO 11608 series of standards. The standards cover requirements, test methods, and design guidance for needle-based injection systems, and they are currently nearing the end of the most comprehensive review and update since 2012.

This review of ISO 11608 aims to better align the various parts of the standard and define a new class of device coming to the market, on-body delivery systems (OBDS), which the current revision of the standards doesn’t adequately describe. CDP develops and verifies many needle-based injection systems on behalf of our clients. Our manufacturing capability also gives us insight into the challenge of moving from building a handful of devices to building thousands of products. The Final Draft International Standard will be published soon, and I’d like to share some of the proposed changes.

It’s important to note that the current status of these standard parts is “draft”. The details of these documents may well change before publication, assuming that the various international bodies approve the publication of these standards. That said, let’s get into some detail.

ISO 11608 – update history in brief

Since the publication of ISO 11608-1: Pen Injectors for Medical Use – Requirements and Test Methods in 2000, the standard has expanded to cover many aspects of needle-based injection systems (NIS). The various parts of the published standards now cover:

General Requirements (11608-1 since 2012)
Needles (11608-2)
Finished Containers (11608-3)
Electronic and Electromechanical Injectors (11608-4)
Automated Functions (11608-5)

These standards were then joined by 11608-7 (Accessibility for persons with visual impairment) in 2016, which covers design guidance for improving accessibility to NIS for visually impaired users. These parts of the standard come under the remit of ISO Technical Committee 84 (ISO TC84), a committee focused on defining the requirements and test methods to ensure safe and effective devices are made available to the widest number of people.

I’ve had the privilege of being one of the UK’s representatives to this committee since 2013, so I’ve had a front-row seat for many of these discussions. So, what changes should device manufacturers and designers anticipate?

ISO 11608-1 – Needle-based Injection Systems

In this revision of the 11608 family, TC84 has worked to align the various parts, ensuring every potential NIS is addressed in the collection of parts, that they integrate well, and topics aren’t duplicated. ISO 11608-1 is the ‘parent’ part – the fundamental section of the standard that establishes the requirements and test methods for all NIS devices covered by the whole standard.

The revision to part one includes the introduction of OBDS (more fully described in ISO 11608-6) and several new concepts. These concepts include primary function, the functions of the device that allow it to be used safely and effectively. Functional stability, which expands testing regimens to simulate whole-life testing for reusable devices, is also introduced in this revision. In addition, the design specification for the NIS must consider the impact and requirements of the medicinal product, and the guidance on risk-based design approaches has been expanded.

There are also several smaller modifications to ISO 11608, including moving all requirements for electronics and EMC testing to ISO 11608-4, the addition of a choking hazard warning for small components, and the associated test fixture. A section has also been added to the document giving guidance on design verification with reference to ISO 13485.

ISO 11608-2 – Double-ended Pen Needles

The changes to ISO 11608-2 (Double-Ended Pen Needles) are more subtle. The determination of flow rate has been expanded to include suggested flow ranges and the sample sizes have been brought in line with the requirements in ISO 11608-1. The testing requirements to confirm compatibility between a needle and a specific NIS have been revised to include dose delivery and needle hub removal force. In addition, the samples required for functional compatibility have been reduced and guidance has been added regarding the requirements for the inner needle shield.

ISO 11608-3 – Containers and Integrated Fluid Paths

The scope of ISO11608-3 has now been expanded beyond defining cartridge geometry and performance to cover NIS Containers and Integrated Fluid Paths. Again, this change has been prompted by the development of OBDS. The requirement for resealing the cartridge has been reduced from 1.5x the intended use to a minimum of 1.0x the intended life. At the same time, the particle size for coring characterization has increased from 50um to 150um or larger. General requirements for soft cannulas and fluid line connections have also been added – another feature of the standard that can be traced back to introducing the OBDS class of device. Cartridge geometry definition has also been moved to an informative annex, meaning it’s no longer mandatory.

ISO 11608-4 – Needle-based Injection Systems Containing Electronics

I’ve had no direct visibility of the updates to ISO 11608-4. However, colleagues from the dedicated work group have summarized the two high-level changes as:

an expansion of the scope to include all electronics on a NIS (not just those concerned with the delivery of the drug product)
medicinal product delivery while connected to mains power (for recharging the battery) will be permitted

The challenge for part 4 has been to reference the parts of IEC 60601 which are appropriate for NIS. Part 4 references IEC 60601 explicitly, adopting the general requirements, means of patient protection, and power input requirements from the relevant components of the standard. The minimum ingress protection has been increased from IP22 to IP52, allowable temperatures for skin contact are defined, failure obvious to the user after free fall preconditioning is permitted, and the use of NIS in oxygen-rich environments has been defined.

ISO 11608-5 – Automated Functions

The revised text for ISO 11608-5 now explicitly directs the reader to ISO 11608-1 for general requirements and focuses on automated needle insertion and dose delivery. Requirements for fenestrated needles (needles with holes in the side) have been defined and the implications of non-perpendicular needle and cannula insertion are explored. The dose accuracy test has been modified for needles with automated insertion, and defining and measuring automated dose delivery time is now a requirement.

ISO 11608-6 – On-body Delivery Systems

This review includes the introduction of ISO 11608-6 defining the requirements for OBDS. This part of the standard initially expanded quickly as new terms and definitions were added but many of the new concepts have been adopted into the following component documents: 11608-1 (General Requirements), 11608-3 (Container and Integrated Fluid Paths), and 11608-5 (Automated Functions).

The crucial difference between an OBDS and an infusion pump is that the OBDS’s performance is defined by dose accuracy for a fixed volume; an infusion pump is defined by the rate at which the medicinal product is delivered. OBDS are also distinct from other NIS types in that they are attached to the body, whereas traditional NIS are held by the user for the duration of the delivery. The requirements and design guidance reflect this difference in use and the concept of a delivery profile (as a characterization tool, not a performance requirement) has been included to help device builders better understand their products.

This summary only scratches the surface of the comprehensive review of ISO 11608, and on the current timeline, these changes will not be published until late 2022, but if your development program extends beyond that date, I hope you found this summary helpful. The draft standards can be purchased from the ISO web store if you’d like to better understand the scope of the changes and the implications for your device development and verification program. If you’re a device developer and struggling with device performance, CDP has expert teams to help overcome these problems.

I’d like to thank my colleagues from ISO for their assistance in drafting this summary. In particular, Robert Nesbitt, Director of Portfolio Strategy at Abbvie and project leader for the ISO 11608-1 review, and Bibi Nellemose and Lars Brogaard from Danish Standards, whose tireless efforts as TC84’s secretariat keep the whole process running smoothly.

By Cambridge Design Partnership

October 19th 2020

Circularity in context

Picture the scene: a room full of executives are watching a presentation on company strategy (actually, let’s move with the times… they’re all at home, watching on Zoom). A simple, elegant image of a circle dominates the screen. Will they support the adoption of circularity principles across the business? In unison, they nod. Not only is this the right thing to do, but it’s what the rest of the market is doing. Circularity is an essential component of a forward-looking business strategy.

But in each of their minds is a nagging question… How?

Why is circularity important?

“Circularity” is a word that has become ubiquitous in the sustainability strategies of many of the world’s biggest brands, from Apple (variations of the term ‘circular’ appear 27 times in their latest sustainability progress report) to AstraZeneca. Spearheaded by advocacy groups like the Ellen MacArthur Foundation, the concept has intuitive appeal: maintaining the value invested in materials and products for as long as possible seems like good sense, given the effort, skill and resources required to produce them. It should also be good news for a planet that is running out of capacity to supply us with raw materials and soak up our waste.

Behind the elegant concept of circularity, however, is an incredibly diverse range of steps with varying degrees of applicability – and environmental benefit – in a given situation. But the need to simplify this into marketing messages and calls to action has led to Circularity becoming a buzz word, applied so broadly that it risks becoming meaningless. Companies, keen to move into this green and pleasant new vision for the economy, are looking for simple, off-the-shelf ‘cricular’ measures that they can adopt quickly – sometimes at the expense of a proper assessment of whether the approach is appropriate and truly beneficial for them, their customers or indeed, the environment.

In this blog, we look at why Circularity in Context is of fundamental importance and the approach CDP takes, working in partnership to provide our clients with the best possible sustainable outcomes, instead of pushing a square peg into a circular hole…

Context is King

Take this as an example. An enthusiastic company want to generate a new beverage offering that is due to launch in an up and coming developing market – let’s call it ‘Circular Soda’… for now. They want something that has the kudos of being ‘Circular’, which seems an attractive USP for a marketing message. Time is spent identifying the right grade of rPET (recycled PET plastic); starting with a circular material in the first place seems like a great idea. But… when the brand launches with sustainable claims emblazoned on the label, it’s not long before journalists realize that this ‘recyclable’ rPET is not being recycled in practice, as there is no recovery or recycling infrastructure in this market! Context is king… had the company thought it through a ‘circular’ solution, based around recycling, is actually not the best fit for this market, even if it is perfect for other regions. Sadly, in some instances, this kind of example is not that far from the truth.

A great real-world example is our old ‘frenemy’ the plastic bag. Few are aware that this innovation in 1959 had sustainable circularity front and center in the mind of its Swedish designer, Sten Gustaf Thulin. Sten calculated that a plastic bag that could be reused time and time again was a far more durable and far less energy intensive product than the common 1950s cotton or paper bags. He always carried his beloved innovation in his pocket, just in case he found himself doing a spot of shopping… (70 years later we find ourselves reaching into our own pockets for Sten’s reusable bag, in a consumer culture that aspires to be more circular… if only we could remember not to leave them in the car!) Unfortunately, the context that became king in the 1950s and decades following was convenience. Bags were so cheap to produce and so desirable for consumers as a disposable convenience, that Sten’s planet-positive pack has become a slur on sustainable living. This is where the introduction of filters in the process of innovation is key. What are the factors that might pervert intended circularity, and how can the design counter this?

Back in the boardroom, chief execs are still looking at the circle on the screen and scratching their heads with a killer question in mind.

How do we put circularity in context?

At CDP, our Circularity in Context model enables client teams to look at a brief through a broader lens, with the ability to consider what’s happening now as well as what will influence innovation in future, via 4 key filters that will help drive our understanding of which circular opportunities are most applicable. These filters extend far beyond the business or product itself, looking at the wider ecosystem and emerging trends that are shaping it.

The societal filter looks at the ways in which governance and politics influence the markets our clients are operating in, and how society as a whole might embrace or reject certain opportunities due to attitudinal or legislative parameters for change. This can drive future regulation, infrastructure development, or R&D investment.
The economic filter helps us understand ‘viability for change’ from a commercial perspective; what commercial pressures occur in the context that their brand and product is operating in? What criteria are used to appraise investments? What is the existing asset base?
The user filter puts us in the shoes of the end users, either ‘consumers’ (B2C) or customers (B2B); how should a proposition meet their needs and does a move toward a more circular solution provide gains or create pains for them? How might their habits and behaviors have a positive or negative impact on the viability of a more circular solution?
The technological filter is an exceptionally important one that’s often overlooked. CDP rely on a broad group of experts with deep knowledge in science and technology to determine how a ‘circular idea’ can become a technically viable reality, as well as identifying emerging technologies that could enable new business models in the future.

As much as people want to be unfettered when pursuing creative thinking on how to adopt circular approaches, these filters constitute whether a circular concept could become a viable reality for our clients. So, developing a brief with our clients for a successful outcome with these filters underpinning innovation – aiming to be circular, but doing it in context – is the key to success.

Game-changing?

As a team of researchers, designers, engineers and innovators, we want to develop great sustainable products! Much of the focus of current efforts to embed circularity into products has focused on utilizing circular materials; the leaders in the field are extending their ambition to more resilient, returnable or repairable models. A great example of the adoption of ‘game changing’ circular thinking, at different levels, now exists within the Toy industry. The first level in improved circularity is moving from dispose to recycle; at the end of 2019 Mattel announced its goal to achieve 100% recycled or recyclable plastics in its products and packaging by 2030. New entrants to the toy market (such as Toy-Cycle and Whirli) have gone a step further and established a ‘recommerce’ platform, where outgrown toys are shipped directly to the company to be sorted, repaired, resold and returned into the system. This commercial model for a lending library – recycling parts, not materials – is perfectly in keeping with a new generation of consumers who don’t want to condemn their child’s personal plastic Toys “R” Us store to landfill, or even the recycling bin. The societal context is shifting!

However, being circular in our choice of materials and components is often only one opportunity; bigger ones might exist if we are willing to look beyond the product as it is today. We opt for a telescope before a microscope – we’re interested in the detail, but we’re just as interested in the bigger picture, where the big innovations often lie. Applying systems thinking and looking beyond circular material usage could uncover a totally new way of delivering the benefits people currently derive from the existing product.

Some entrepreneurial businesses have had a eureka moment when their context is well placed to offer them the chance to do something radical and reimagine a product, system or service altogether. With the games industry booming, (in no small part due to the current pandemic), this year it’s set to reach a phenomenal $159.3 billion in sales¹. With many asking where the potential for growth is, innovation has pivoted away from games linked to hardware formats. Inspired by smartphone innovation and leveraging an expertise in cloud computing, Google Stadia and Amazon Luna have emerged as serious challengers to established players such as Xbox and Playstation. Hardware tomorrow will be so yesterday. Brands in this new gamer age look like the style of their landing pages and the quality of their games and content, not the console or the cartridges or discs that once ran on them. By 2021 video gaming sales are due to hit the $200 billion mark; one can only imagine how the absence of hardware will increase the profit margins within this behemoth entertainment industry.

By considering the wider context around a business, and how this might change in the future, it’s possible to identify opportunities that – like in the game-changing example – offer enhanced value to customers precisely because they are more circular and less reliant on consumption of materials. As the famous quote goes, “People don’t want to buy a quarter-inch drill. They want a quarter-inch hole”!

A partnership approach

We are known for working in close partnership with our clients (it’s in the name!), but also for offering an evidence-based, independent perspective when assessing circular options and the surrounding context using both a telescope and a microscope. We believe this approach can de-risk circular innovation strategies by identifying opportunities that fit the situation, and even reimagine the product or service entirely. Circularity is definitely not one-size-fits-all – but with careful consideration of context, we think there is a circular opportunity that’s right for everyone.